The Journey to a State of Control

By John N. Butts, Ph.D.

A success story is emerging for environmental pathogen control during the production of pre-packaged, sliced lunchmeats and hotdogs. Efforts to reduce risk and provide a greater margin of safety for these high-risk products appear to be working. The journey by producers has been marked by a pathway of systematic improvements from facility design and new ingredients to microbial interventions on equipment and products.

Measures of success include the following:

• There have been no confirmed illnesses in the U.S. from Listeria in federally inspected meat products since 2003.

• The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) routine monitoring of results from all plants producing ready-to-eat (RTE) products.

Our History
Milestone events that have enabled the journey include the following:

• 2004 Lactate and diacetate began large-scale usage in meat and poultry products as a Listeria inhibitor

Preceding and during this period, several Listeria outbreaks and large recalls dotted the landscape. Both public health and business risks had to be reduced. These events became milestones because the industry leadership was not satisfied with the status quo. A change was needed.

These cross-functional, industry-wide efforts produced “Best Practices,” Principles of Facility and Equipment Design and interventions that effectively removed or killed the organism in its harborage location. There is no one single Critical Control Point (i.e., no silver bullet), but a portfolio of proven tools that facilitate intervention and control.

The game plan was not perfect, but those producers who implemented the best practices experienced risk reduction. Our suppliers were recognized for their efforts. This new level of control is becoming a win-win situation for the consumers of our products, our suppliers and the industry as a whole.

Evolution of Best Practices and Simple Lessons Learned
Let’s dissect this success. How has the entire processed meats industry accomplished this task?

First, I strongly believe this success could have been derailed by a regulatory focus on product action at the first sign of the loss of control. Instead, the FSIS facilitated this success by encouraging companies to find the root cause of the contamination or potential contamination. They encouraged improvements by not over-regulating in the early years after the pathogen fully emerged and was associated with outbreaks. Plants were given the opportunity to develop their own control programs. Regulatory guidance promoted aggressive sampling for Listeria spp. Establishments investigating a problem were allowed to find more Listeria spp.-positive environmental transfer points without a mandatory finished product-sampling scheme that could have easily changed the focus from investigative to a broad-scale, compliance-based, finished product sampling effort. The temptation was to inspect safety into the process via finished product sampling. Strong efforts were made by both regulators and industry to allow the investigation to proceed without excessive regulatory intervention. Investigations needed to focus on finding the growth niche. At the plant level, processes often needed to operate to facilitate the movement of the organism in order for the transfer vector to be located that would lead the investigation to the growth niche. The progress and effectiveness of the corrective and preventative actions were shared with the agency. Over time, process control prevailed in those plants deploying the industry best practices.

Product contamination is the result of the pathogen being moved from its protective harborage site (growth niche) to the product or product contact surface. A high-risk situation occurs when the vector of movement places the organism in the Zone 1 area (i.e., product contact surface or above a product contact surface). The transfer vector can originate far away from the point of product contamination. Our experience includes instances where the source of contamination was in a Zone 4 area (non-RTE area). In these instances, the transfer occurred via personnel, equipment and/or tool movement. The pervasive nature of this organism often results in the harborage location being discovered in unexpected, hidden locations.

Food Safety Is Not Competitive
These understandings led to the development of best practices that eliminated the harborage location or minimized the potential for the transfer of the organism. These practices were the foundation of The AMI Principles of Sanitary Design for both Equipment and Facilities.

Examples of the principles include the following:

• Clean to a microbiological level (visual clean, while important, is not the key process indicator)

• Physical separation of raw and RTE plant areas

• Eliminate growth niches such as hollow rollers

There are, in total, 10 Equipment and 11 Facility Principles of Sanitary Design. These principles formed the foundation that fostered continuous improvement of sanitary design in our industry. Our suppliers joined the journey by providing improved designs that eliminated or enabled control of harborage areas.

Another cross-functional, industry-wide effort was ongoing while the Sanitary Design Principles were being developed. AMI sponsored Listeria Intervention and Control Workshops, bringing together Food Safety, Quality Assurance, Sanitation, Maintenance, Engineering and Manufacturing Management. The workshops enable participants to share experiences and learn from one another.

Presentation topics include the Basis of Control, Sanitation Methods, Sanitary Equipment Design, Sanitary Facility Design, Developing a Routine Sampling Plan for Process Control, Construction Process Control, Validation and Verification of Intervention Strategies, Lot and Line Segregation, Data Analysis, Investigation and Corrective Action. Case Studies are presented that unveil situations that led to best practices. Group breakout sessions challenge the participants to develop plans to address real life, high-risk situations. During this 10-year timeframe, workshop participants were exposed to the new interventions and best practices as they evolved. Participants not only gained knowledge of how to use simple measures to prevent or minimize risk, they were encouraged to challenge their paradigms that prevented aggressive sampling and application of non-traditional interventions. The workshops provide a medium for the parti-cipants to explore “outside of the box” and take that thought process back to their places of work.

Roadblocks to the Journey
There have been roadblocks for some companies. Roadblocks are exemplified by living with a known or recognized problem. For instance, a slicer has been found to have repetitive positives. The solution is to redesign or to manage. To many, this solution is obvious. To some, it is impossible. If redesign is not possible and complete disassembly is not practical, then the slicer could be treated with heat (or steam) sufficient to kill all the organisms residing in the growth niche. Examples of equipment commonly and routinely heat treated to control internal growth niches include slicers, conveyors, collators, plastic barrels, product totes, hand pallet jacks, electric pallet jacks, maintenance tools and product racks. Other roadblocks include a failure to effectively investigate a positive monitoring result.

A contact surface positive should result in an investigation. The investigation method to determine if a piece of equipment is a source of the contaminating organism is to perform a “Seek and Destroy” mission (Figure 1).

That piece of equipment should be completely and fully disassembled. Samples are taken for both aerobic plate counts and Listeria species. Observations for excessive organic matter are conducted. Data is produced to determine whether the organism was harboring in that piece of equipment.

Unfortunately for some companies, the only corrective and preventative action performed is to clean and sanitize the transfer point that was positive then to resample the same contact surface transfer point. This may appear to be a solution, but the pervasive nature of the organism will prevail. This is a textbook example of firefighting. As long as the growth niche is present and the transfer vector is capable of transport, this problem will be solved over and over again.

Control
The Seek and Destroy Process is the accepted scientific method to:

• Find pathogenic growth niches

• Find potential growth niches that require monitoring

• Define normal level of disassembly

• Define periodic deep level of disassembly

• Define frequency of periodic deep level of disassembly

• Qualify a new piece of equipment (run for 90 days then conduct Seek and Destroy Mission)

• Validate effectiveness of equipment cleaning protocol

• Validate effectiveness of intervention applied to a piece of equipment

The JourneyThat light at the end of the tunnel may not be a train—at least for some. The journey to a state of environmental control can be broken into parts and described as stages (Table 1).

Often, companies avoid having to go down this path by having a “successful microbiological” monitoring program. They sample regularly and never find a positive! Successful environmental monitoring is finding a positive, not a trigger for regulatory enforcement. Sampling plans need to be designed to find the organism. Investigative sampling directed towards high-risk situations should produce enlightening data. Plants with excellent controls do find positives. Those positives are typically from indicator sites designed to trigger preventative action. These positives enable the plant to take preventative action while the risk level is low, before a contact surface or product positive is encountered.

Food Safety Management is more than just sampling and reporting results. Its responsibility is to move the establishment along this journey from the “Awareness Stage” to the “Predictive Stage.” Failure to effectively use or deploy preventative practices keeps the establishment in a “firefighting state.” In this state, management promotes not getting to the root cause and rewards solving the same problem over and over again.

Food Safety Management must create and cultivate a company culture that promotes preventative action. Data then can drive the preventative mindset to a predictive state where actions are taken in advance of the potential problem becoming a high-risk situation. Join the journey. The continuous improvement pathway is marked with proven best practices.

John N. Butts, Ph.D. is vice president of research at Land O’ Frost, Inc. He received his B.Sc. in Agriculture and M.Sc. in Food Science from Kansas State University and his Ph.D. in Food Science from Purdue University. He is a member of the Institute of Food Technologists, the American Society for Quality, Poultry Science, the American Meat Science Association, the Institute of Packaging Professionals and the International Association of Food Protection.